Composition for the treatment of hoof conditions in hoofed animals

ABSTRACT

Composition for the topical treatment of hooves of hoofed animals comprising a curing agent preferably comprising bay leaf oil and/or turpentine oil and a fungicide, and optionally a bactericide. A method for the preparation of the composition. A method of treatment of hooves of hoofed animals suffering from white line disease, hoof thrush and/or hoof rot. Use of a fungicide and optionally a bactericide in the manufacture of a composition for topical treatment of diseased hooves of hoofed animals.

The present invention relates to a composition for the treatment ofhooves in (one- and/or two-) hoofed animals and a method for thetreatment of hoofed animals.

The invention is also directed to a new and improved method for treatingwhite line disease and hoof thrush in horses or in other equine animalssusceptible to hoof thrush and white line disease and for treating hoofrot in sheep, goat and cattle. By “equine animals” is meant a horse,donkey, mule, burro or zebra. However, the preferred animal is a horse.Hereinafter, the term “horse” encompasses all equine animals.

White line disease in horses is a disease that has not been very welldocumented. White line disease can cause severe discomfort for the horseand, if not well groomed, the horse will become cripple or lame.

The white line is generally considered to be that section of the hoofwhere the farrier places the nails when shoeing the horse. The whiteline disease is an affection of the stratum internum, which is theinside part of the hoof. The disease will cause a disruption of thewhite line, other than the disruption caused by normal influences fromthe outside such as small stones, sand and the like. The disruptionscaused by such normal influences are usually superficial and willdisappear upon regular trimming of the hoof. The white line diseasegenerally tends to spread out more and deeper into the hoof. If thedisease spreads out at proximal distance a void will form. The void willbe surrounded by the horn of the stratum lamellatum on one side and thestratum internum or medium on the other side. This situation is commonlyknown as “hollow wall”. The hoof then becomes brittle. The horse willexperience considerable discomfort from this situation. The generallyused remedy to limit the damage is regular and extensive trimming of thehooves. However, in many cases this does not solve the problem of whiteline disease.

By hoof thrush is meant a disease in horses of the hoof and frog tissuecaused by a variety of pathogenic micro-organisms. By hoof rot is meantan analogous disease of the hoof in sheep, goats and cattle. Thediagnostic signs of thrush disease or hoof rot include a strongunpleasant odour and discharge from the frog tissue. A veterinarian ofordinary skill can readily determine whether a horse exhibits a thrushinfection or white line disease or whether a sheep, goat or cow exhibitsa hoof rot infection.

A schematic drawing of the hoof is given in FIG. 1.

In an article in the “Tijdschrift voor Diergeneeskunde, 1995, 120, 18,pp 526-529”, white line disease has been investigated in a population ofhorses in the Netherlands. A mycological investigation of the hoofmaterial was carried out. It was found that Scopulariopsis brevicauliswas detected in 60% of the animals with an abnormal white line or withhollow wall or with seedy toe. The reported remedy against white linedisease, hollow wall or seedy toe is based on the conventional treatmentwhich is the extensive trimming of the hooves and removal of affectedmaterial. Other remedies or treatments are not given or suggested.

From WO89/07385 it is known that hoof thrush in horses and hoof rot inother animals is primarily caused by an anaerobic bacterium,Spherophorus necrophorus. The application describes a remedy based onthe use of metronidazole (1-(2-hydroxyethyl)-2-methyl-5-nitroimidazole)in various forms and treatments.

It has now been found that a composition comprising a curing agent and afungicide is very effective in the treatment of white line disease, hoofthrush and hoof rot. The invention thus relates to a composition for thetopical treatment of hooves of one- and/or two-hoofed animals comprisinga curing agent and a fungicide.

The curing agent in the composition is in general an agent which has aantiseptic and/or disinfecting effect. The curing agent, or caringagent, can also have other characteristics which can attribute to thewell being of hooves. The active components in the curing agent areselected from the group consisting of bay leaf oil, medicinal turpentineoil, tea tree oil, lavender oil, bergamot oil, eucalyptus oil, pine oil,rosemary oil or mixtures and combinations thereof, preferably bay leafoil, medicinal turpentine oil and/or tea tree oil or mixtures andcombinations thereof. The curing agent is present in an amount up to 30wt. %, preferably from 5 to 25 wt. %, more preferably from 10 to 20 wt.%. The fungicide in the composition can be any suitable fungicide aslong as it is active against the fungus that is found in white linedisease, hoof thrush or hoof rot. Preferably the fungicide expressesactivity towards Scopulariopsis brevicaulis. The fungicide is selectedpreferably from the group consisting of enilconazole, clotrimazole,miconazole, sulconazole, econazole, oxiconazole, tioconazole,thiabendazole, naftifine, terbinafine, tolnaftate, itraconazole ormixtures and combinations thereof, preferably enilconazole,clotrimazole, miconazole or mixtures and combinations thereof. Thefungicide is present in an amount up to 20 wt. %, preferably from 5 to15 wt. %, more preferably from 7 to 12 wt. %. In a preferred embodimentthe invention encompasses a composition for the topical treatment ofhooves comprising

preferably Curing agent up to 30 wt. % 5-25 wt. % Fungicide up to 20 wt.% 5-15 wt. % Emulgator up to 50 wt. % 20-30 wt. % solvent/diluent to 100wt. % to 100 wt. %

In different embodiments, such as an ointment, the composition mayadditionally comprise compounds such as a cetylester or like compounds.For use as a conditioner a basis composition can be prepared which cansubsequently be diluted to a concentration that is suitable forapplication to the hoof. Alternatively the composition can be in theform of a gel. The previously described afflictions of hooves are alsoinfluenced by the presence of bacteria. If the hoof suffers from theseafflictions, bacteria may enter the damaged areas and cause furtherinfections. This will not only cause additional discomfort, but alsohave a detrimental influence on the healing process in general. To avoidthis, it is possible and desirable to have a bactericide present in thecomposition according to the invention. The bactericide is preferablyselected from the group consisting of chloroxylenols, triclosan,chlorhexidine, octopyrox or mixtures and combinations thereof,preferably triclosan and/or chloroxylenols or mixtures and combinationsthereof. The fungicide is present in an amount up to 20 wt. %,preferably from 5 to 15 wt. %, more preferably from 7 to 12 wt. %. Thecomposition can be provided in any suitable form such as a solution,emulsion, powder, ointment, spray, gel etcetera. The composition can befurther brought in a suitable form by the addition of diluents,carriers, excipients, adjuvants, emulgators, dyes, colorants, perfumesand the like. The composition can also be mixed with known products forgrooming or tending of hooves.

The present invention also relates to a method for treating white linedisease, hoof thrush (in a horse) or hoof rot (in a sheep, goat or cow)comprising topically administering a therapeutically effective amount ofthe composition in a carrier directly on a thrush or hoof rot infectedarea for a treatment period effective to cure the thrush or hoof rotinfection.

The present invention encompasses a method for the topicaladministration of the composition in the form of a solution or in theform of a gel, salve or ointment at and/or near the area affected bywhite line disease or the thrush or hoof rot infected area.

For topical administration in the form of a solution, the active drugcomponent of the present invention, in liquid, powdered or lyophilisedform may be combined with a suitable pharmaceutical diluent or carrier(collectively referred to herein as “carrier” materials) such as water,saline, aqueous buffers, and the like. The method of application of thecomposition in the form of a solution may be by pouring, squirting,flushing or sponging the solution on the thrush or hoof rot infectedarea. In a preferred embodiment for treating thrush, a disposableplastic syringe (without a needle) may be filled with some of thecomposition solution for treatment and squirted on the thrush infectedis area. Alternatively, the horse's hoof may be submerged or immersed orsoaked in the solution according to the invention to effect thetreatment. In severe cases, such a soaking treatment may be necessary toeffectively cure the thrush. In a preferred embodiment for treating hoofrot, the sheep, goat or cow is walked through a foot bath containing thesolution.

The hooves of the animals in general are also carriers of bacteria andmay even be infected by bacteria, for example by dung or faeces. Whenthe same solution is used to treat different animals cross-contaminationof the hooves between the animals may occur. The presence of thebactericide in the composition can also account for the prevention ofcross-contamination.

For topical administration in the form of a gel, salve or ointment, thecomposition as above may be combined with a suitable carrier. The methodof application of the composition in the form of a gel, salve orointment may be by contacting and rubbing the gel, salve or ointment on,in, around and throughout the thrush hoof rot or white line diseaseinfected areas of the animal's hoof and frog.

Regardless of the form and method of administration selected (e.g.solution, gel, salve, ointment), the composition is formulated intopharmaceutically acceptable dosage forms by conventional methods knownto those skilled in the art.

Regardless of the form and method of administration selected, anon-toxic but therapeutically effective amount of the composition isemployed in any treatment. The dosage regimen for treating white linedisease, hoof thrush or hoof rot is selected in accordance with avariety of factors, including the medical condition of the animal, theseverity of the infection and the form of administration. A veterinarianof ordinary skill can readily determine and prescribe the effectiveamount required to cure the infection. In so proceeding, theveterinarian could employ relatively low doses at first and subsequentlyincrease the dose until a maximum response is obtained.

With the composition according to the invention the treatment of hoovescan effectively be achieved by treating horses over a period of, forinstance, twelve to twenty weeks by a footbath three times a week duringfive or ten minutes. After that it is advantageously to apply a weeklyfootbath as a preventive treatment. An advantage of the invention isthat the horn of the hooves improves in quality and the growth of hornis stimulated.

A composition according to the invention, wherein the active componentsare incorporated in an emulsion in water, is one wherein the compositioncomprises 5-10% bay leaf oil, 0.1-0.2% medicinal turpentine oil, 20-30%cetylester such as cetyl palmitate and/or cetylstearate, 5-8% miconazoleor enilconazole or itraconazole, 20-30% of an emulgator such as apolysorbate and or a laurate, preferably sorbitollaurate in an organicsolvent such as ethanol or methanol, the composition is diluted withabout 50 parts of an aqueous solution.

A most preferred composition is one wherein the composition comprises 9%bay leaf oil, 0.15% medicinal turpentine oil, 23% cetylester such ascetyl palmitate or cetylstearate, 6.6% miconazole or enilconazole, oritraconazole, 25% of an emulgator such as a polysorbate and/or alaurate, preferably sorbitollaurate in an organic solvent such asethanol or methanol, the composition is diluted with about 50 parts ofan aqueous solution.

The invention also encompasses a method for the preparation of thecomposition according to the invention.

A preferred example of the method according to the invention comprisesthe steps of:

a. homogenising bay leaf oil, medicinal turpentine oil and cetylester;

b. homogenising miconazole or enilconazole or itraconazole withemulgator and solvent until a homogenous solution or suspension isobtained;

c. mixing and homogenising the mixtures obtained in the previous steps.

To obtain a composition which can be readily used, the followingadditional steps are performed:

d. mixing and homogenising a part of the composition obtained under cwith an equal part of water with a temperature of 60-80° C.;

e. adding, mixing and homogenising another two parts of water with atemperature of 60-80° C.

It is to be noted other sources of ingredients or other ingredients thanthe above described can be used. For instance, by starting from the pureand commercially available compounds, the process for the preparation ofthe composition may deviate from the one herein described in a mannerwhich is obvious to the man skilled in the art, without detracting fromthe gist of the invention. It is also possible to employ commercialavailable compositions comprising curing agents, fungicides andbactericides, respectively. The different compositions are mixed until asuitable homogenous composition is obtained by using variations of theprocess which variations are known to the man skilled in the art.

The obtained emulsion is diluted with 50 parts water and homogenised. Afootbath is filled with this solution until a depth of about 5 cm. Thehorses are placed in the solution for a period of 5-10 minutes. It isadvantageously to treat all horses, not only the horses with theafflictions as mentioned and to continue the treatment until all horsesare free from the afflictions. After that it is advisory to continue thetreatment on a more or less regular basis for instance every two weeks.

By not diluting the mixture obtained under e. an ointment is obtainedwhich can be used as such.

The ointment can advantageously be used for the prevention of thementioned afflictions by applying the ointment previously to the shooingof the horse.

The mixture and the solution prepared from the mixture canadvantageously be used with sheep, goat and cow when hoof relatedinfections or hoof rot occur.

EXAMPLES

Composition

An aqueous solution of 100 liter was prepared with the followingingredients:

2020 ml of a concentrated solution of enilconazole, containing 100 mg/mlenilconazole (obtained from Janssen-Cilag, brandname Imaverol)

3 liter of a solution containing chloroxylenol(4-chloro-3,5-dimethylphenol, obtained from Sigma-Aldrich) in 96%ethanol

1250 ml of a composition containing 280 mg/g bay leaf oil and 1.5 mg/gturpentine oil.

Some preferred compositions that can be used for different treatments ofhooves are summarised in the following table, all amounts are grams per1000 gram of the total composition.

cleaner conditioner ointment anti thrush curing 1 10 270 5 agentfungicide 1 28 11 20 bactericide 1 15 11 20 cetyl ester >0 >0 708 >0 orother basis emulgator + 20 >0 >0 solvent 120 (ethanol) Balanceconventional water ethanol/ shampoo water sequestrans + /detergent + =present in unknown amount

The different compositions can be used as follows:

Hoof cleaner can be used as a regular shampoo.

The conditioner is in the form of an emulsion which can be diluted 10-20fold, preferably 14 fold. The conditioner can be applied as a solutionfor instance in a bucket or a hoof bath.

The ointment can be used as such. The anti thrush composition is in thefrom of a thin viscous gel which is used as such and can be applied witha tampon.

The table contains the preferred compositions of the differentembodiments. The curing agent, the bactericide and the fungicide may becombinations of the respective curing agents, bactericides andfungicides. For instance, in the compositions of the table the curingagent is a mixture of bay leaf oil, medicinal turpentine oil and teatree oil 2/2/1 w/w/w, the fungicide isenilconazole/clotrimazole/miconazole 1/1/1 w/w/w, and the bactericide ischloroxylenol/triclosan 1/1 w/w.

1. Flushing

In general, each hoof to be treated was cleaned with a hoof pick. Thepick was used to remove material in and around the frog and heel. Insome cases, the hooves were not preliminarily cleaned with a hoof pick,but treated directly with the solution containing the composition.

The solution can be applied by spraying or with a syringe.

2. Soaking

Several horses were treated by soaking the hooves in the solution. Ingeneral, a bath or a bucket was filled with the solution. Each thrushinfected hoof, after it was cleaned with a hoof pick, was placed in thebucket containing the solution and was completely submerged and soakedin the solution for approximately 20 minutes. Each hoof was submergedand immersed in the solution. The time of soaking ranged fromapproximately 20 seconds to 60 minutes.

Soaking of the hooves can be accomplished in a variety of manners whichwill be sketched below;

1. Each hoof is placed separately in a bucket. The bucket contains thesolution. The hoof is submerged and soaked during a period ofapproximately 20 minutes.

2. The horse is lead into a treatment box. The box restrains themovement of the horse and the bottom of the box is a bath. After thehorse is placed in the box, the bath is filled with the solutioncontaining the active components. The hooves are completely submergedand soaked in the bath to allow the active ingredient to reach allclefts and crevices of the hoof. The bath can also contain a spongy matwhich is soaked with the solution.

3. The horse is being treated with a rinsing shoe. The leg of the horseis placed in the rinsing shoe and the rinsing shoe is then filled withthe solution. The hoof is soaked in the solution.

4. The horse is being treated with an easy boot, generally used fordamaged hooves. The shoe is applied and filled with the solution and thehoof is soaked.

5. The horse is being treated with an easy boot, whereby the boot isfilled with cotton balls soaked in the solution.

6. The voids in the hoof are filled with cotton balls which are soakedin the solution and subsequently wrapped in (self-adhesive) bandages.

7. A horseshoe whereby between the iron and the hoof a plate of plasticor leather is applied. The hoof is filled with cotton balls soaked inthe solution. The plate will keep the cotton balls in place. This canalso be accomplished with an iron plate which is attached to thehorseshoe with bolts or clamps.

8. A textile bag lined with leather or plastic is placed around the hoofand filled with the solution containing the active ingredient.

The above described methods of treatment are intended to be exemplaryonly, other methods of treatment are imminent to the skilledpractitioner. The essence is that by soaking the hooves an effectivetreatment of the hooves with the active ingredient is obtained and theactive ingredient is allowed to reach all clefts and crevices of thehoof.

Example 2 Treatment of Thrush Infected Hooves Using Ointment

Treatment Procedure

Preliminarily, each hoof to be treated was cleaned with a hoof pick aspreviously. The pick-cleaned hoof was lifted and held while the ointmentcontaining the active ingredients of the composition was rubbed on, in,around and throughout the affected white line and the voids or thethrush infected areas of the hoof and frog tissue, including the sulcaeof the frog tissue. The ointment was sometimes applied using a brush toinsure that the ointment gets into all clefts and crevices of the heeland frog tissue. The treated hoof may be left exposed or may be coveredwith paper to protect the treated hoof. A paper covering of the hoof wasprepared as follows. The shape of the hoof was traced onto a brown paperbag. The paper was then cut to the shape of the hoof and shoe. The paperwas trimmed to fit inside the hoof and was tucked under the shoe, whereit remained as a protective cover for the treated hoof.

Another way of treating the frog tissue is to use a cotton ball immersedin a concentrated solution of the composition according to theinvention. The cotton ball is placed in the groove which is caused bythe thrush. The cotton ball is refreshed on a regular basis.

The grooming of the hoof is necessary. During the washing or bathing thenatural protection from the hoof will be removed. Therefore it isadvisable to apply an ointment on the hoof after bathing.

It is most preferred that after soaking in anyway of the hoof with thesolution the hooves are treated with an ointment containing thecomposition according to the present invention.

Example 3 Treatment of Hoof Rot Infected Hooves

Preparation of the Foot Bath

The solution is poured into a foot bath to yield a solution in the footbath that is 5-7 cm deep so as to allow immersion of the animal's hoofup to the coronet band or hairline. The dimensions of the foot bathshould be such that it takes 15-30 seconds for the animal to walkthrough the foot bath.

Treatment Procedure

Preliminarily, each hoof to be treated may be (but need not be) cleanedwith a hoof pick to remove packed material in and around the frog andheel. Each sheep, goat or cow to be treated is then walked through afoot bath prepared. The period of each treatment should be at least15-30 seconds.

Treatments of Different Horses

Several horses have been treated, using procedures as describedpreviously. The results are summarised below;

Horse 1 (by the name of Kigali): The horse suffered from hoof thrush onall four hooves. The horse has been treated with the anti-hoof thrushformulation for the period of one week. Every day a fresh cotton ballwas placed in the thrush, one day with the formulation, the other day aclean cotton ball was applied. Result: After a week the affectedthrushes dried. After two weeks the thrushes had a healthy look andshowed a normal development.

Horse 2 (Jerremy): The horse suffered from a combination of hoof thrushand white line disease. Treatment was carried out in the hoof bath andin a similar manner to horse 1. After two weeks the hoof thrush wascured. The white line disease was treated over a period of five monthsduring which twice a week the horse was placed in the hoof bath andafter bathing the hooves were treated with the ointment. After thistreatment the hooves were trimmed and returned to the normal model andquality. The structure of the hoof was tougher and therefore the hoofwas stronger.

Horse 3 (Ideaal): All four hooves were strongly inflicted by white linedisease. During six months the horse was treated in a hoof bath. Duringthe treatment the quality of the hooves markedly improved.

Horse 4 (Voltaire): The horse had two different hooves, one normal, theother flat and weak. By treating the bad hoof in the hoof bath, the hoofobtained a better structure and the form returned to normal.

Horse 5 (Ike): The horse suffered from a light form of white linedisease. During two months the horse was treated twice a week in a hoofbath and a third month the treatment was reduced to once a week. Afterbathing and in between treatment the hooves were treated with theointment. The result was that the hooves were free of afflictions.

Horse 6 (Fjord): The horse had two affected hooves. After treatmentduring three months, the hooves were again in a good condition.

What is claimed is:
 1. A method of treatment of hooves of hoofed animalscomprising contacting the hooves with a composition comprising a curingagent and a fungicide; wherein the fungicide is selected from the groupconsisting of enilconazole, clotrimazole, miconazole, sulconazole,econazole, oxiconazole, tioconozole, thiabendazole, naftifine,terbinafine, tolnaftate, itraconazole and mixtures or combinationsthereof; wherein the curing agent is selected from the group consistingof bay leaf oil, medicinal turpentine oil, tea tree oil, lavender oil,bergamot oil, eucalyptus oil, pine oil, rosemary oil and mixtures orcombinations thereof; and wherein the hoofed animal suffers from whiteline disease, hoof thrush or hoof rot or combinations thereof.
 2. Amethod of treatment of hooves of hoofed animals comprising contactingthe hooves with a composition comprising a curing agent, a fungicide anda bactericide; wherein the fungicide is selected from the groupconsisting of enilconazole, clotrimazole, miconazole, sulconazole,econazole, oxiconazole, tioconozole, thiabendazole, naftifine,terbinafine, tolnaftate, itraconazole and mixtures or combinationsthereof; wherein the curing agent is selected from the group consistingof bay leaf oil, medicinal turpentine oil, tea tree oil, lavender oil,bergamot oil, eucalyptus oil, pine oil, rosemary oil and mixtures orcombinations thereof, and wherein the hoofed animal suffers from whiteline disease, hoof thrush or hoof rot or combinations thereof.